Duns Number:081325959
Device Description: Intracranial Pressure and Temperature Monitor
Catalog Number
CAM02
Brand Name
CAMINO®
Version/Model Number
CAM02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121573,K121573
Product Code
GWM
Product Code Name
Device, Monitoring, Intracranial Pressure
Public Device Record Key
55154b00-a64a-4bfa-85e6-36fed201d3b9
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 28, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |